BACKGROUND: Gastrointestinal stromal tumors (GISTs) are mesenchymal tumors most often caused by activating mutations of the KIT gene. KIT tyrosine kinase inhibitors provide targeted therapy for the underlying genetic mutation, and adjuvant therapy is indicated for patients who are at significant risk of relapse following GIST resection. This is a report of the safety of imatinib in patients with GIST in the adjuvant setting in an expanded access program. METHODS: In this multicenter, open-label, single-arm trial, safety was assessed based on the frequency of adverse events (AEs). RESULTS: Three hundred patients were treated and analyzed; 40 patients discontinued treatment. Median overall exposure during the program was 181 days (range 9-420); most patients (260/300 treated) completed the study. Six patients had disease recurrence, 4 of whom discontinued. In line with previously published reports, the most frequent AEs were nausea, diarrhea, and periorbital edema. The AEs were mild to moderate in most cases (76%). CONCLUSIONS: These findings are in agreement with the known safety profile of imatinib and confirm the safety of imatinib at 400 mg/day in the adjuvant setting. The incidence of severe AEs was low.

Adult Mesenchymal Tumour and Rare Cancer Medical Oncology Unit Cancer Medicine Department Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

Department of Internal Medicine 3 University Hospital Grosshadern Ludwig Maximilians Universität München Munich Germany

Department of Medical Oncology Gustave Roussy Institute of Oncology Villejuif France

Department of Medical Oncology Sarcoma Center West German Cancer Center University Hospital University of Duisburg Essen Essen Germany

Department of Medical Oncology University Hospital Virgen de las Nieves Granada Spain

Department of Oncology and Palliative Care Sarcoma Center Berlin Brandenburg Helios Klinikum Berlin Buch Berlin Germany

Department of Oncology Medical Centre Hungarian Defense Forces Budapest Hungary

Department of Oncology Palacky University Medical School and Teaching Hospital Olomouc Olomouc Czechia

Department of Oncology University Hospital Motol 2nd Faculty of Medicine Charles University Prague Czechia

Division of Medical Oncology University Hospital A Gemelli Rome Italy

Novartis Farmacéutica Barcelona Spain

Novartis Pharma GmbH Nuremberg Germany

Oncology Region Europe Origgio Italy

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